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Senior Quality Officer (QEs and CAPAs)

PrimeVigilance

Greater London

On-site

GBP 40,000 - 60,000

Full time

4 days ago

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Job summary

A leading company in the pharmaceutical sector is seeking a Senior Quality Management Officer to ensure compliance with regulations regarding Quality Events and CAPAs. In this role, you will lead investigations, manage the Quality workflow, and support continuous improvement projects within a diverse and supportive work environment.

Benefits

Training and career development opportunities

Strong emphasis on personal and professional growth

Friendly working environment

Qualifications

Relevant experience in a Quality and/or Compliance-related role.
Prior experience in Pharmacovigilance, Medical Information, or Medical Devices is preferred.

Responsibilities

Lead the administration, tracking and management of Quality Events and CAPAs.
Co-ordinate root cause investigations.
Provide training and coaching to junior team members.

Skills

Quality Management

Root Cause Analysis

Compliance

Education

University degree in Biomedical sciences, Natural sciences or Health Sciences

Tools

Electronic Quality Management System

6 days ago Be among the first 25 applicants

Job Description

The Senior Quality Management Officer is responsible for ensuring that Quality Events (QEs) and Corrective and Preventative Actions (CAPAs) are completed in accurate and timely fashion and are managed in compliance with global regulations, legislation and PrimeVigilance requirements.

Lead the administration, tracking and management of QEs and CAPAs at PrimeVigilance
Co-ordinate root cause investigation meetings and support Subject Matter Experts to conduct efficient root cause analysis
Lead QEs and CAPAs management through the workflow
Provide support to operations and act as subject matter expert on process of managing QEs and CAPAs
Participate and lead in business process optimization and continuous improvement projects / activities
Exercise oversight over timely completion of action items (CAPA and Effectiveness checks) for QEs raised for US projects
To participate in audits and inspections to act as a QE and CAPA subject matter expert (SME)
Provide training and coaching to train the business operations and junior QE and CAPA team members with regards to Quality Management
Support the line manager for periodic trending of deviations data across the company
Provide peer review of QE work performed by colleagues
Respond to audit findings and audit requests

Qualifications

University degree in Biomedical sciences, Natural sciences or Health Sciences is required
Relevant experience in a Quality and/or Compliance-related role
Prior experience in Pharmacovigilance, Medical Information, or Medical Devices
Experience of using an electronic Quality Management System desirable but not required

Additional Information

We prioritize diversity, equity, and inclusion by creating an equal opportunities workplace and a human-centric environment where people of all cultural backgrounds, genders and ages can contribute and grow.

To succeed we must work together with a human first approach. Why? because our people are our greatest strength leading to our continued success on improving the lives of those around us.

We Offer

Training and career development opportunities internally
Strong emphasis on personal and professional growth
Friendly, supportive working environment
Opportunity to work with colleagues based all over the world, with English as the company language

Our core values are key to how we operate, and if you feel they resonate with you then PrimeVigilance could be a great company to join!

Quality
Integrity & Trust
Drive & Passion
Agility & Responsiveness
Belonging
Collaborative Partnerships

We look forward to welcoming your application.

Seniority level

Seniority level
Mid-Senior level

Employment type

Employment type
Full-time

Job function

Job function
Quality Assurance
Industries
Pharmaceutical Manufacturing

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